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December 31, 2012 Issue

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Preparing to bring to market their Clever Cap™ Device that leverages a Wireless-Data Communication Platform that Senses and Can Control and Count the Actual Number of Pills Taken out of a Vial on a Near Real-Time Basis, CleverCap is solving the Medication Adherence Problem

Moses Zonana

An experienced serial entrepreneur and CEO, Mr. Zonana has embarked on a variety of technology and healthcare startups. He founded TLeMAZ, a Mobile Virtual Network Operator that serviced credit challenged customers; NetLogistiK, an Internet market place to connect shippers and carriers for optimizing cargo space. Most recently, he served as CEO of Reliance Meds, a nationwide service provider for Medicare, Medicaid and HMOs and founded Mesh Venture Partners to leverage technology in the healthcare industry. He is responsible for incubating a variety of startups including: USAMedCard™, a medical/pharmaceutical discount card for the uninsured, Caretricity™, an on-line pricing engine to connect patients and physician practices; and Compliance Meds Technologies, creator of the CleverCap™ solution. Before becoming an entrepreneur, Mr. Zonana was an Associate in the Derivatives Risk Technology group of Morgan Stanley. Mr. Zonana obtained a BA in Mathematics, with highest honors, from Rutgers University and an MBA from Harvard Business School.


About CleverCap:

Compliance Meds Technologies is a health management service company in the US that specializes in the design and implementation of innovative technology to solve common medication use challenges for patients and providers. The Company’s lead product is Clever Cap™, a device-enabled adherence solution that leverages a wireless-data communication platform to help patients take prescriptions as directed and avoid medication misuse.


Prescription Technology


Turnberry Plaza
2875 NE 191st Street, Suite 403
Aventura, FL 33180



Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – December 31, 2012

Mr. Zonana, what is the overall vision at CleverCap today?

Mr. Zonana: We believe that there is a better way of managing medication adherence in the healthcare space. We understand from years of experience in healthcare that there is no current solution that monitors medication use in between refills and we believe that we can make an impact in reducing hospital readmissions, reducing costs, and improving patient outcomes with technology. We are working towards that end initially with CleverCap, but we will be releasing a number of other technologies over the coming years.


CEOCFO: Would you explain how the CleverCap system works?

Mr. Zonana: Essentially, CleverCap is a cap that replaces a standard cap on a prescription vial. You can think of the CleverCap as a small computer residing on your prescription with digitally embedded instructions on how to take your medication; it is the digital equivalent to the printed label on the surface of the prescription vial. When it is time to take your dose, it will remind you with visual and sounds alerts. If you miss a dose, there is a notification platform that will inform you or your support system that you did. Your adherence information is recorded using specialized activity sensors and it gets transmitted using near real-time communication protocols. Every time a pill capsule or tablet gets out of the vial, the information is transmitted, recorded and aggregated in our reporting platform. Available reports help patients work towards better adherence rates. Aggregated adherence information can be very helpful to health providers to understand trends.


CEOCFO: Are you able to take the cap off and just take out a pill if you wanted to?

Mr. Zonana: No, you cannot. Well, you can, but you are not supposed to. There is a tamper-proof lid that prevents you from simply just opening the cap and taking as many pills as you want to. You can tamper and take as many as you want to, but we will visually flag the event. Pills are supposed to come out of a sliding door that is embedded in the cap, the functioning of it is controlled by the dose based on your regimen. We also provide what we call an emergency release dispense that lets you take pills off-schedule


CEOCFO: Has a system or concept like this been tried before, or is this a totally new idea?

Mr. Zonana: There have been attempts to solve the medication adherence problem. The majority of other systems had based their approach on sensing when a cap is open or close, but there had not been a solution to control and count the actual number of pills taken out of the vial on a near real-time basis. There are also ‘smart blister’ approaches that monitor when a pill is taken out, but those solutions are costly and don’t act as reminders at the same time. Considering the tradeoffs between form- factor, degree of integration with existing supply chains and affordability, CleverCap is by far the best solution out there.


CEOCFO: Has the medical community been actively looking for a better way to monitor, or have they not been paying enough attention to the problem?

Mr. Zonana: There is significant interest from the medical community. However, issues related to reimbursement structures had prevented these types of technologies to proliferate. The medical community had primarily been under a fee for service structure and there were no codes for incremental reimbursement based on medication adherence monitoring. The situation is changing with new regulations and reimbursement structures to prevent readmissions that align provider’s economic incentives to better care by way of ACOs and other structures.


CEOCFO: I would imagine insurance companies are looking for something that will ultimately save them money, do you agree?

Mr. Zonana: Yes, managed care organizations are responsible for expenses on the clinical side as well as for medication utilization. There are a number of studies that show that improved medication adherence rates can save costs in the thousands of dollars per patient per year even after considering the increased expenses from incremental medication utilization


CEOCFO: You mentioned have audio alerts that will beep when it is time for the dosage, is that correct?

Mr. Zonana: Yes, there are audio and visual alerts, and if you miss your dose we transmit messages; either by phone and by way of an IVR, similar to how you receive flight reservation reminders; by email or text messages. The notified parties are approved by the patient to comply with privacy regulations.


CEOCFO: Where are you in the development process?

Mr. Zonana: We have been in R&D for a little over a year and a half. We recently made it public that we are in the process of commercialization. We are in conversations with a number of parties, both in pharma and in managed care, and even on the research channel for clinical trials. We are ready to manufacture and deliver during the first quarter of the upcoming year.


CEOCFO: Are there any regulatory issues that need to be complied with, or is it a type of product that really does not fall under any?

Mr. Zonana: CleverCap is classified under FDA product code NXQ as “medication reminder” and as such it does not have to go through an extensive FDA approval process. There are some regulatory requirements like registering establishments and undergoing child safety and senior-friendly tests to comply with the poison prevention packaging act.


CEOCFO: What else might you be working on?

Mr. Zonana: Right now, CleverCaps work with standard pill vials. We are going to refine it to work with the smallest diameter vials too. We are also working on solutions that can integrate a number of different medications to help patients with multiple therapies when concurrent adherence monitoring is necessary.


CEOCFO: Development and commercialization is always costly; is CleverCap funding to get through the next steps, or will you be seeking additional funding?

Mr. Zonana: Yes, we were funded in the summer. We will be exploring new funding sources next year. 


CEOCFO: Why should CleverCaps standout for investors and people in the business community?

Mr. Zonana: We created a solution that is simple to use for the patient, with an elegant form factor, that fits perfectly into existing pharmaceutical dispensing supply chains, that is easy to utilize by health practitioners to improve upon existing data sets for care and disease management programs and that solves one of the biggest problems in healthcare.


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“We created a solution that is simple to use for the patient, with an elegant form factor, that fits perfectly into existing pharmaceutical dispensing supply chains, that is easy to utilize by health practitioners to improve upon existing data sets for care and disease management programs and that solves one of the biggest problems in healthcare.”- Moses Zonana


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